check_circleStudy Completed

Erythema

Efficacy of Dexpanthenol in thermic erythema

Trial purpose

The study focuses to prove the equivalent efficacy of two different Dexpanthenol formulations.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • - Healthy subjects
    - Phototype: I to IV according to Fitzpatrick scale
  • - Pregnant or nursing women
    - Subjects registered as being in exclusion period in the French Health Minister file of subjects
    - Subjects with known allergy to cosmetics, skin care products, or topical drugs, a sensitivity related to any component of any formulations being tested

Trial summary

Enrollment Goal
55
Trial Dates
September 2007 - September 2007
Phase
Phase 2
Could I Receive a placebo
No
Products
Dexpanthenol (BAY81-2996)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
VILLEURBANNE, 69100, France

Primary Outcome

  • Global sum of scores for evaluating the cooling/soothing effect evaluated after first and second application
    date_rangeTime Frame:
    2 min, 5 min, 10 min, 15 min
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Skin temperature
    date_rangeTime Frame:
    2 min, 5 min, 10 min
    enhanced_encryption
    Safety Issue:
    no
  • Evaluation of the cooling/soothing effect (scores) after first and second application
    date_rangeTime Frame:
    2 min, 5min, 10 min, 15 min
    enhanced_encryption
    Safety Issue:
    no
  • Evaluation of the foam covering properties after first application
    date_rangeTime Frame:
    2 min, 5 min, 10 min, 15 min
    enhanced_encryption
    Safety Issue:
    no
  • Incidence of adverse events
    date_rangeTime Frame:
    FPFV - LPLV
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Evaluation of the effect of Bepanthen burn relief foam spray new formula on a thermic erythema. Equivalence trial. Intra-individual design.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2